At Press Time

ACA: Few Immediate Eye-care Impacts

By Bill Kekevian, Associate Editor

Longer-term will see an increase in patient flow.

■ With President Obama’s re-election, both the Republican Speaker of the House, Rep. John Boehner and medical societies, including the AAO, are ready to embrace the Affordable Care Act (ACA) as “the law of the land.” That’s not to say there aren’t some lasting gripes.

“I accept this legislation, as a spokesperson, as the law of the land,” says Michael X. Repka, MD, AAO medical director for governmental affairs. “But there are some aspects of it we’re not very happy about.”

Dr. Repka is fielding numerous calls and e-mails about the new legislation. He’s on a public awareness campaign to separate fact from rumor. The first myth he’s sure to dispel: The ACA will completely restructure your practice.

In reality, he says, “I would not expect a huge change for [ophthalmologists].” Some misinformation arises out of political confusion, he says. “Some of the problem is that people confuse the ACA with news about the fiscal cliff, SGR and other legislation.”

2014 A Key Year

However, that does not mean the legislation will not bring about changes. For instance, insurers will be mandated to provide vision care as an essential benefit for children, but not until 2014. And while one of the law’s more popular provisions is that people younger than age 26 may be covered under their parents’ insurance starting in 2014, Dr. Repka notes that is not a high-volume group in terms of eye disease.

But worrying about an increase in patient flow isn’t far off, Dr. Repka says. Starting in 2014, “ophthalmologists will be seeing more diabetics who might have had no correction before because they didn’t have coverage,” he says. With the potential for 30 million new covered lives, patient flow is bound to increase, he says. Some of those patients are bound to have cataracts and some are going to have AMD, he notes.

To prepare for greater patient flow, practices should begin shoring up their patient management processes, Dr. Repka says. One strategy practices may want to consider is adding providers, he says.

Medicare and Medicaid

Closing the Medicare drug coverage gap is one aspect of the ACA that goes into effect this year. This ACA provision will begin the phasing-in of federal subsidies for brand-name drugs filled in the Medicare Part D coverage gap, reducing co-insurance from 100% in 2010 to 25% in 2020. This provision also includes a 50% manufacturer brand-name discount.

Most ophthalmologists will not notice the impact of Medicaid changes, “unless you have a high Medicaid population, but most ophthalmologists don’t,” says Paul Larson of Corcoran Consulting Group. “Most of the changes taking place in 2013 are related to the inpatient side of the equation. From a coding and reimbursement side, the ACA is way low on my radar.”

Possibly the most controversial ACA provision for physicians will not take effect until 2015, Dr. Repka says: The Independent Payment Advisory Board (IPAB). “One of the objections is physicians are the only group impacted by it,” he says. “The IPAB’s only tool is to cut costs, and since they can’t cut benefits they can only reduce payments.”

An average of 30% of specialists’ revenues, depending on the subspecialty, derive from Medicare, according to William Rich III, MD of the AAO.

If there’s a developing health-care trend of note, Mr. Larson adds, it’s that accountable care organizations are “growing in the background” of the ACA reforms. “Hospitals are swallowing up specialties,” he says.

FDA to Help Speed Device Approvals

Agency joins with private company in cooperative effort.

■ The FDA, which has come under increasing fire from medical device companies frustrated with slow approval processes and a new 2.3% gross receipts tax, has become part of the first public-private partnership to promote advances in medical device regulatory science. The focus of the partnership is on speeding the development, assessment and review of new medical devices.

The new Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation, created by LifeScience Alley (LSA), a biomedical science trade association. MDIC will receive input from industry, government and other nonprofit organizations. MDIC will prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and the pathway to market for these innovations.

The FDA said the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products is critical to the medical device industry and public health. Advancements in what the FDA calls “regulatory science” not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market. For example, a computer model might be developed to test an implant on a virtual patient before a manufacturer invests the time and money to study that product in a clinical trial.

A More Efficient Process

The goal of MDIC is to bolster the country’s investment in regulatory science research by pooling people, funding, resources and ideas to develop new tools, models and methods that may be utilized to better and more efficiently evaluate new devices. FDA staff may collaborate with the MDIC on MDIC-supported research and other projects.

“By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

FDA Commissioner Margaret Hamburg, MD, told a press conference that a large part of medical device innovation stems from small startup companies that do not have the research funding to effectively test their products at an early stage of development. MDIC would be able to use the best ideas from industry, government and academia, she said.

“This can best be done by making sure we’re applying the best science to the task and bringing together the best minds, no matter where they are found,” Dr. Hamburg said.

In the News …

■ UAB begins glaucoma detection program. The University of Alabama at Birmingham, with a $1.9 million grant from the Centers for Disease Control and Prevention, is launching a telemedicine glaucoma detection program in which OCT devices will be installed at two independent Alabama optometrists’ offices with a centralized image-reading center at UAB, stated a press release issued by the university.

The program is primarily focused on early detection in an underserved demographic: African-American patients older than age 40.

“Our current model of eye care is simply not reaching one of the most at-risk populations for glaucoma, older African-Americans,” says Christopher Girkin, MD, ophthalmology chairman and program director. “Historically, this is an underserved population, who are less likely to seek professional eye-care services in a standard clinical setting. So we’re going to see if we can take appropriate vision care to them.”

Once images of a patient’s eyes are electronically transmitted from one of the optometrist’s offices to the UAB center, the UAB center will report glaucomatous findings to the optometrist, who will then be able to start treatment.

“Early detection of glaucoma is the key to treating the disease and slowing its progression,” Dr. Girkin notes. “The vast majority of glaucoma cases can be treated with medicine, especially in the early stages.”

The program is set to launch in February or March, says a UAB spokesperson.

Eye Movements Slower in Glaucoma Patients

New evidence glaucoma is a neurodegenerative disease.

By Rene Luthe, Senior Associate Editor

■ Researchers at St. Michael’s Hospital, University of Toronto, have offered further proof that glaucoma is a neurodegenerative disease affecting major vision pathways, according to a recent published in Eye and Brain.

The prospective study of 16 patients with glaucoma vs. 21 control subjects examined saccadic eye movements and found those with glaucoma showed delayed eye reaction movement times of approximately 15%. This delay was present at all stages of the disease. Because the brain signals for saccadic eye movements are thought to travel a different route from the optic nerve to the back of the brain than other signals from the optic nerve, the investigators’ findings seem to indicate a new vision pathway in the brain affected by glaucoma.

Additionally, the study may help explain why glaucoma patients have an increased risk of falls and car accidents, since rapid eye movements are involved in many everyday activities including reading and scanning the surrounding environment.

“Determination of median saccade reaction time may offer a novel functional test to quantify visual function in glaucoma patients,” the investigators wrote. “Further studies are needed to determine pathological processes implicated in delayed initiation of saccades and to assess whether alteration of saccades affects daily activities in glaucoma patients.” Lead investigator was Neeru Gupta, MD, chief of glaucoma at St. Michael’s.

Reference

■ Glaucoma medication gets FDA approval. Sucampo Pharmaceuticals said the FDA has approved a supplementary NDA for Rescula (unoprostone isopropyl) 0.15% for lowering IOP in patients with open-angle glaucoma or ocular hypertension. Sucampo intends to launch Rescula in the first quarter of 2013.

According to the approved product labeling, Rescula may be used as a firstline agent or concomitantly with other topical ophthalmic drug products to lower IOP. Rescula is a BK (big potassium) channel activator, which the company says is different from other IOP-lowering agents.

The FDA initially approved Rescula in 2000 for lowering IOP in open-angle glaucoma and ocular hypertension in patients who could not tolerate to other IOP-lowering medications or responded poorly to them.

■ New cataract surgery approval for LensAR. LensAR Inc., developer of a next-generation femto-phaco laser system for refractive cataract surgery, said its system has FDA received 510(k) clearance for executing corneal incisions during cataract surgery.

The LensAR Laser System is now FDA cleared for all the critical components of laser cataract surgery, including lens fragmentation, anterior capsulotomy (with or without phacofragmentation) and corneal incisions. The company is currently selling the LensAR system to cataract surgeons in the United States, Europe and elsewhere around the world.

“By securing this regulatory clearance for corneal incisions, LensAR is now able to offer surgeons another critical tool for optimizing patient safety, satisfaction and outcomes in connection with cutting-edge laser cataract surgery,” said Louis “Skip” Nichamin, MD, member of LensAR’s medical advisory board. “The company’s advanced imaging-guidance technology enables surgeons to execute the precise and self-sealing incisions that play such a critical role in a patient’s overall experience and outcome.”

■ Visual impairment on the rise. The prevalence of nonrefractive visual impairment (not due to a need for glasses) in the United States has increased significantly in recent years, which may be partly related to a higher prevalence of diabetes, an associated risk factor, according to a study in reported in JAMA.

“It is estimated that more than 14 million individuals in the United States aged 12 years and older are visually impaired (<20/40). Of these cases, 11 million are attributable to refractive error. In the United States, the most common causes of nonrefractive visual impairment are age-related macular degeneration, cataract, diabetic retinopathy, glaucoma, and other retinal disorders,” according to background information in the article.

Previous studies have shown that visual impairment is common in people with diabetes. “The prevalence of diagnosed diabetes has increased among adults in recent years, rising from 4.9% in 1990 to 6.5% in 1998, 7.9% in 2001, 10.7% in 2007, and 11.3% in 2010,” the article stated.

Time to Replace SGR Model

New payment and delivery systems advocated.

■ Eighty-two percent of respondents to a survey by the Medical Group Management Association said they would likely explore new payment and delivery models if stability was restored to the Medicare physician payment system. Under the current SGR guidelines, huge payment cuts are threatened annually and require last-minute Congressional action to avert them.

The research also showed that if payments were stable for five years, a majority of practices would be willing to explore alternatives to fee-for-service. Medicare accountable care organizations, bundled payments and comprehensive primary care initiatives were all among the alternatives considered.

“Our research shows that physician practices are willing to engage in new Medicare payment and delivery models that reward high-quality, cost-effective patient care outside of fee-forservice,” says Susan Turney, MD, president and CEO of MGMA.

Dr. Turney advocates repealing the SGR and calls for “patient-centered approaches” to payments. The study received responses from more than 1,000 group practices and 26,000 physicians.

In the News …

■ Report: B + L up for sale. Bloomberg News recently reported that the private equity firm Warburg Pincus has asked Goldman Sachs Group to test the interest of leading health-care firms in purchasing its Bausch + Lomb eye-care business. Sources told Bloomberg News that Warburg Pincus may be asking approximately $10 billion for B + L, but bidders may only be interested in paying about $8 billion.

Among the companies reportedly already contacted as possible buyers are Merck, Abbott Labs, Sanofi and GlaxoSmithKline.

If Warburg Pincus cannot attract a suitable buyer, it may conduct a public offering of B + L shares. Warburg Pincus originally purchased B + L in 2007 for $3.7 billion.

■ Trial begins for dry eye drug. Eleven Biotherapeutics, a biopharmaceutical company designing and developing protein-based biotherapeutics, has initiated a phase 1b clinical trial to evaluate EBI-005, its lead ophthalmic protein product, in patients with dry eye disease. EBI-005 is a designed topical protein that inhibits the IL-1 (Interleukin-1) receptor. The phase 1b clinical study, expected to be completed in the first half of 2013, follows a successful phase 1a study of EBI-005 in recent weeks.

“A critical need remains for more effective, topically administered treatment options for patients with dry eye disease because a significant proportion of patients do not receive optimal relief of their symptoms of dry eye disease with currently available therapies,” said Gary N. Foulks, MD, FACS, professor emeritus at the University of Louisville.

The phase 1b clinical trial is a double-blind, multicenter, randomized, placebo-controlled study to evaluate two doses of EBI-005 over six weeks. The trial is expected to enroll up to approximately 80 subjects and will be conducted in nine centers throughout the United States. The primary objective of the study is to determine the safety of EBI-005 and, in addition, use the Ocular Surface Disease Index and fluorescein staining to measure the biological activity of EBI-005.

■ Refractive surgery results at Lackland AFB. Ophthalmologists at Lackland Air Force Base, Texas, have reported a remarkably low incidence of microbial keratitis in their PRK and LASIK patients. Vasudha Panday, MD, and colleagues reviewed all 24,446 cases of PRK and LASIK from January 2005 to December 2011 and identified only one case (0.0041%) of microbial keratitis. That is well below the numbers reported in a 2008 ASCRS study that found the incidence of microbial keratitis cases at 0.091% of all refractive surgery patients. Findings were presented at the recent AAO annual meeting.

The low incidence of infection may be related to the fact that the patients were young, healthy and subject to a strict follow-up protocol.

■ OptiMedica gets new funding. OptiMedica Corp. has received a new $35 million growth round of financing. Proceeds will be used to continue the global commercialization of the company’s Catalys Precision Laser System for cataract surgery, support the development of innovative system enhancements and fuel a next-generation portfolio of additional products.

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